BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BRACCO INJEENERING TRANSFER SET

    K Number: K133147 · Decision Jun 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    246

    Basic Information

    Device Name
    BRACCO INJEENERING TRANSFER SET
    K Number
    K133147
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BRACCO INJENEERING S.A.
    Date Received
    October 17, 2013
    Decision Date
    June 20, 2014
    Product Code
    PQH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PQH Iodinated Contrast Media Transfer Tubing Set

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PQH), ordered by most recent decision date.

    Liebel-Flarsheim IBP Transfer Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDRAD Imaging Bulk Package Transfer Spike

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDRAD® Imaging Bulk Package Transfer Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ulrich Transfer Set

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all